Vaccines’ technology transfer: process and engineering challenges in a fast moving era

This October 22nd from 10.30 to 11.15 am CET join our free live webinar!

Technology Transfer has always been a hot topic and can be even more challenging for complex processes/products like biotechnological ones.

In this Covid-19 pandemic era, different companies are facing technology transfer processes as a mandatory way to boost their Covid vaccines production and follow patients’ need, shifting a series of contract manufacturers across the world that must inherit their technology and achieve compliance in a really short timing to meet the production goals.

Transferring a process means taking what was developed in one original company and replicate it into another one: it seems easy but only on the paper! Equipment, utilities, methodologies and documentation can be very different between different companies and this can represent a real challenge once a process needs to be transferred. Moreover, once the transfer is completed successfully it has to be validated, time constraints are also present, even more in the current challenging situation.

Agenda

10.30 - 11:15 a.m. CET – Live presentation

Part 1. Introduction to technology transfer, peculiarities
of biopharmaceuticals/vaccines technology transfer activities

Part 2. Technology transfer requirements and documents
Process perspective and engineering perspective

Part 3. Technology transfer execution
Process perspective and engineering perspective

Part 4. Management of a successful
vaccine/biopharmaceutical technology transfer

Part 5. Vaccines/Biopharmaceutical technology transfer
case studies and peculiarities

Speakers

Stefania Cislaghi

GMP Compliance Advisor & Auditor

Stefania holds a Biotechnology degree and have always worked in pharma industries since her graduation thesis period. She started working at the bench using molecular biology and biochemistry techniques to produce proteins involved in cancer development. During the first years of work she decided to perform a Master in Preclinical and Clinical Drugs Development, to further enhance her understanding in Quality Assurance, Toxicology, Clinical trials and drugs’ market. In the meantime she started working in a GMP regulated environment, developing processes and analytical methods for monoclonal antibodies to be used as orphan drugs and contributing to the building up of a quality system and products compliance with EMA and FDA requirements. Then, as she is an entrepreneurship passionate, she decided to perform an MBA at Politecnico of Milan, while raising up her responsibilities in her work. She has been a project leader for different biotechnological products development, from engineering up to process validation and she has been responsible for a part of the development and production activities for more than 7 years.

Her strong experience in biotechnological products and processes is now helping PQE customers reaching their goals in the complex world of biotechnological products and ATMPs.